NCT01914302已完成不适用
Lancing Device Blood Volume Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Blood Volumes measured in microliters
研究概览
简要总结
Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
详细描述
Primary Objective:
• Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.
Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:
- Correlation of Subject pain response to blood volume collected;
- Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
- Proportion of Subjects that generate ≥1µl blood volume;
- Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
- Proportion of Subjects who generate multiple- times ≥1µl of blood volume
- Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
- Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be diagnosed with type 1 or type 2 diabetes for one (1) or more year(s).
- •Must be currently self-monitoring blood glucose levels for at least 6 months.
- •Must self-test at least 2 times daily.
- •Must be between the ages of 18 and 75 to participate.
- •Subjects must be able to perform all tasks required in this protocol.
- •Subjects must be willing to complete all study procedures.
- •Subjects must be able to speak, read and understand English and understand the Informed Consent document.
排除标准
- •Subjects with neuropathy or any other nerve damage in the hand or fingers (this will be discovered through the monofilament test)
- •Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded).
- •Subjects taking pain relievers within 24 hours.
- •Subjects with hemophilia or any other bleeding disorder.
- •Subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis).
- •Subjects having a condition such as a cognitive disorder, which in the opinion of the Investigator would put the person at risk or seriously compromise the integrity of the study (PI will sign Case Report Form if Subject is excluded).
- •Subjects working for Facet, LifeScan Inc., or a competitive company.
- •Subjects with missing digits.
- •Subjects who are pregnant or nursing.
- •Subjects on chemotherapy.
结局指标
主要结局
Blood Volumes measured in microliters
时间窗: between 1 and 10 days after first visit
Study subject lances assigned finger and acquires blood drop; at that time the study facilitator gathers blood in pipette and measures on scale
次要结局
- Pain rating measure on a 0-20 Gracely Scale(between 1 and 10 days after first visit)
研究者
研究点 (1)
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